title: Reactogenicity and safety of a liquid human rotavirus vaccine (RIX4414) in healthy adults, children and infants in China: randomized, double-blind, placebo-controlled Phase I studies.
abstract: We report the findings of three randomized, double-blind, placebo-controlled Phase I studies undertaken to support licensure of the liquid formulation of the human G1P[8] rotavirus (RV) vaccine (RIX4414; GlaxoSmithKline Biologicals SA) in China. Healthy adults aged 18-45 y (n=48) and children aged 2-6 y (n=50) received a single dose of the human RV vaccine or placebo. Healthy infants (n=50) aged 6-16 weeks at the time of first vaccination received two oral doses of the human RV vaccine or placebo according to a 0, 1 mo schedule. In infants, blood samples were collected prior to vaccination and one month post-dose 2 to assess anti-RV IgA antibody concentrations using ELISA. Stool samples were collected from all infants on the day of each vaccination, at 7 and 15 d after each vaccination and one month post-dose 2. Stool samples were analyzed by ELISA for detection of RV antigen to assess RV antigen excretion. The reactogenicity profile of the human RV vaccine was found to be comparable to that of placebo in all age groups studied. The anti-RV IgA antibody seroconversion rate in infants after two vaccine doses was 86.7% (95% CI: 59.5-98.3). Vaccine take in infants who received the liquid human RV vaccine was 86.7% (95% CI: 59.5-98.3). A Phase III efficacy study of the human RV vaccine in the infant population in China has now been completed (ROTA-075/NCT01171963).
authors.affiliation: Guangxi Autonomous Region Center for Disease Prevention and Control; Nanning City, Guangxi, P.R. China.
authors.forename: Rong-Cheng
authors.initials: RC
authors.lastname: Li
authors.forename: Yan-Ping
authors.initials: YP
authors.lastname: Li
authors.forename: Zhao-Jun
authors.initials: ZJ
authors.lastname: Mo
authors.forename: Dong
authors.initials: D
authors.lastname: Luo
authors.forename: Teng
authors.initials: T
authors.lastname: Huang
authors.forename: Ji-Lian
authors.initials: JL
authors.lastname: Kong
authors.forename: Lao-Hong
authors.initials: LH
authors.lastname: Wang
authors.forename: Ning-Sheng
authors.initials: NS
authors.lastname: Song
authors.forename: Aixue
authors.initials: A
authors.lastname: Liu
authors.forename: Helen
authors.initials: H
authors.lastname: Zhang
authors.forename: Xueyan
authors.initials: X
authors.lastname: Liao
authors.forename: Naveen
authors.initials: N
authors.lastname: Karkada
authors.forename: Htay Htay
authors.initials: HH
authors.lastname: Han
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000032:analysis / Q000097:blood; D002648:Child; D002675:Child, Preschool; D002681:China / Q000453:epidemiology; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D004797:Enzyme-Linked Immunosorbent Assay; D005243:Feces / Q000737:chemistry; D005260:Female; D005759:Gastroenteritis / Q000453:epidemiology / Q000517:prevention & control*; D006801:Humans; D007070:Immunoglobulin A / Q000097:blood; D007223:Infant; D008297:Male; D008875:Middle Aged; D010919:Placebos / Q000008:administration & dosage; D012400:Rotavirus Infections / Q000453:epidemiology / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D044967:Serum / Q000276:immunology; D014611:Vaccination / Q000009:adverse effects* / Q000379:methods*; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral; D007070:Immunoglobulin A; D010919:Placebos; C492457:RIX4414 vaccine; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated
keywords: RIX4414; human rotavirus vaccine; rotavirus gastroenteritis; rotavirus vaccination; vaccine safety